NCT05041400

Brief Summary

The quantification of the strength-producing capacity of the knee joint muscles by isokinetic measurement is one of the most widely used tools for monitoring and deciding whether to return to sport after ACL reconstruction. However, the isokinetic evaluation performed in current practice does not exploit all the measures offered by this exploration technique, which can lead to errors in analysis and interpretation of the results and underestimate its ability to predict a return to sport under optimal conditions. Recently, more complete analysis models than those currently in use and integrating the moment-angle relationship have thus proposed the use of functional ratios sweeping the whole amplitude of the knee joint. Baumgart proposed an analysis of the variation of isokinetic force moments at each angle after ligamentoplasty. This approach seems to be the future of isokinetic performance analyses, but for the moment this has only been used in pathological populations and on small numbers of patients (less than 40). There are therefore no reference values in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

September 23, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

September 2, 2021

Last Update Submit

July 12, 2022

Conditions

Keywords

knee isokinetic angle

Outcome Measures

Primary Outcomes (1)

  • Distribution of knee isokinetic angle

    The primary outcome will be composed of the following elements:(1)- a curve representing the distribution of the mean (and confidence interval) of the normative values of the knee flexors/extensors ratio at each angle on the tested amplitude, (2) a curve representing the distribution of the mean (and confidence interval) of the normative values of the right/left ratio at each angle on the tested amplitude,(3) a curve representing the distribution of the mean (and confidence interval) of the normative values of peak torque (normalized by subject mass) produced by the flexors and extensors at each angle over the amplitude tested, (4)- the distribution of the mean (and confidence interval) of the right/left differential on the value of the peak torque on the flexors and extensors and its angle of occurrence.

    1 DAY

Study Arms (1)

Healthy subjects

OTHER

Evaluation carried out on a BIODEX S4 Pro isokinetic dynamometer after a standardised 10-minute warm-up on this same dynamometer . The measurement range will be from 0° (full extension) to 90° of flexion for each knee, providing 91 degrees of measurement.

Other: Evaluation of the strength of knee flexors and extensors

Interventions

Each participant will benefit from a clinical evaluation and an evaluation of the strength of knee flexors and extensors using an isokinetic dynamometer after a 10-minute warm up.

Healthy subjects

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects,
  • Practicing a regular activity with a minimal activity of two trainings and one competition per week,
  • Practicing this activity from at least 8 continuous weeks,
  • Affiliated or benefiting from public health services.

You may not qualify if:

  • Person presenting any of these conditions: professional player / athlete,
  • patient with systemic pathology or treatment affecting the musculoskeletal system, patient with a history of traumatic pathology or any pathology requiring orthopaedic/surgical treatment of the knee and/or hip and/or spine,
  • patient having a contraindication to an isokinetic test (disabling pain, progressive pathological process, unconsolidated fracture, unbalanced cardiovascular pathology), protected patient (adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision), Pregnant and/or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marc Antoine DEMARET

Toulouse, 31000, France

Location

Related Publications (3)

  • Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.

    PMID: 25157180BACKGROUND
  • Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.

    PMID: 27423208BACKGROUND
  • Baumgart C, Welling W, Hoppe MW, Freiwald J, Gokeler A. Angle-specific analysis of isokinetic quadriceps and hamstring torques and ratios in patients after ACL-reconstruction. BMC Sports Sci Med Rehabil. 2018 Dec 6;10:23. doi: 10.1186/s13102-018-0112-6. eCollection 2018.

    PMID: 30534382BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Marc-Antoine DEMARET, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 13, 2021

Study Start

September 23, 2021

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations